Complying with the HIPAA Breach Notification Rule

The HIPAA Breach Notification Rule ensures that individuals are informed if their protected health information (PHI) is compromised.

Under this rule, covered entities and business associates must:

• Notify affected individuals within 60 days of discovering a breach

• Report breaches involving more than 500 individuals to the Department of Health and Human Services (HHS) and, in some cases, the media

• Maintain internal documentation of all breach investigations, even if notification is not required

To comply, organizations must have:

• Defined incident response and breach notification procedures

• Processes for assessing the risk of harm posed by a potential breach

• Mechanisms for documenting decisions and notifications

Automation and continuous monitoring can enhance breach detection and response—improving both HIPAA compliance and alignment with frameworks like SOC 2 and ISO 27001.